https://www.medexeurep.com/post/mdr-article-16-relabelling-own-brand 2026-09-06 https://static.wixstatic.com/media/78313a_f496fc4c324e4642a9da60dc657ad6ee~mv2.png Own-brand labelling and relabelling under MDR Article 16 deciding who is the manufacturer of a medical device https://www.medexeurep.com/post/ivdr-performance-evaluation-annex-xiii 2026-09-06 https://static.wixstatic.com/media/78313a_b287bcabf6244e608a2980e4450cf0be~mv2.png Performance evaluation documentation for an in vitro diagnostic device under IVDR Annex XIII https://www.medexeurep.com/post/ivdr-authorised-representative 2026-09-06 https://static.wixstatic.com/media/78313a_5d9bc3b05c354274b8b312e4ecf46bc4~mv2.png IVDR authorised representative under Article 11 of Regulation (EU) 2017/746 for in vitro diagnostic medical devices https://www.medexeurep.com/post/medical-device-labelling-requirements 2026-08-30 https://static.wixstatic.com/media/78313a_18d16a05bcf647b9ae3c35a0677a60b1~mv2.png https://www.medexeurep.com/post/pmcf-plan-and-report 2026-09-06 https://static.wixstatic.com/media/78313a_01b5012d27f24f0c8bf54520c6388018~mv2.png Post-market clinical follow-up plan and evaluation report prepared under MDR Annex XIV Part B https://www.medexeurep.com/post/do-you-need-an-eu-authorised-representative 2026-08-30 https://static.wixstatic.com/media/78313a_f69e9fc6388a4201a72038347dc83d80~mv2.png MDR Article 11 test: does a non-EU medical device manufacturer need an EU authorised representative https://www.medexeurep.com/post/placing-on-the-market-vs-making-available 2026-09-06 https://static.wixstatic.com/media/78313a_26e75be7f2eb46fa891a257911161a65~mv2.png Placing on the market, making available and putting into service under MDR 2017/745 explained for non-EU manufacturers https://www.medexeurep.com/post/eu-authorised-representative-in-turkey 2026-08-30 https://static.wixstatic.com/media/78313a_14449dd6e9614915a1875dc592b37101~mv2.png https://www.medexeurep.com/post/uts-registration-foreign-manufacturers 2026-08-02 https://static.wixstatic.com/media/78313a_555494be69eb46c5a5042924916825fd~mv2.png https://www.medexeurep.com/post/choosing-an-eu-authorised-representative 2026-08-30 https://static.wixstatic.com/media/78313a_a7f4af95789644f6a06c3aa0bb82d6b2~mv2.png https://www.medexeurep.com/post/sole-authorised-representative-generic-device-group 2026-09-06 https://static.wixstatic.com/media/78313a_a25ba3ade16441d3ac8c06405414c29b~mv2.png Diagram of a manufacturer portfolio divided into generic device groups, each with one EU authorised representative under MDR Article 11 https://www.medexeurep.com/post/annex-xvi-non-medical-products 2026-09-06 https://static.wixstatic.com/media/78313a_9512d154e548493ea37c7a4d77091118~mv2.png Aesthetic laser and dermal filler products representing MDR Annex XVI groups of products without an intended medical purpose https://www.medexeurep.com/post/custom-made-devices-annex-xiii 2026-09-06 https://static.wixstatic.com/media/78313a_ed26d623b1e7461289ce1527731a886d~mv2.png https://www.medexeurep.com/post/authorised-representative-liability 2026-09-06 https://static.wixstatic.com/media/78313a_6805e68261c74ee782bea44dab84e622~mv2.png EU authorised representative liability for defective medical devices under MDR 2017/745 Article 11(5) https://www.medexeurep.com/post/mdr-transition-period 2026-08-30 https://static.wixstatic.com/media/78313a_a67ed3a9f859416aa91a434e99b06f29~mv2.png https://www.medexeurep.com/post/post-market-surveillance-mdr 2026-08-15 https://static.wixstatic.com/media/78313a_a378e4deec8945b8a23df763b5b8ac10~mv2.png https://www.medexeurep.com/post/udi-carrier-requirements 2026-09-06 https://static.wixstatic.com/media/78313a_b42835e95dc3463f90122219dcec2369~mv2.png Barcode UDI carrier printed on a medical device label and outer carton, illustrating MDR 2017/745 Article 27 and Annex VI Part C placement rules https://www.medexeurep.com/post/mdr-article-11 2026-08-30 https://static.wixstatic.com/media/78313a_8f21f9cc211c4909aac6bd9b84419cc4~mv2.png https://www.medexeurep.com/post/emdn-code 2026-09-09 https://static.wixstatic.com/media/78313a_0df78765501248639e8530386e93ecaf~mv2.png https://www.medexeurep.com/post/what-an-eu-authorised-representative-cannot-do 2026-09-06 https://static.wixstatic.com/media/78313a_4e638a9deb8e4306adb57ed2485440d6~mv2.png Diagram contrasting manufacturer obligations under MDR Article 10 with the limited authorised representative tasks permitted by Article 11(3), showing the Article 11(4) delegation boundary https://www.medexeurep.com/post/psur-article-86 2026-09-06 https://static.wixstatic.com/media/78313a_cf8a9010c4c94a15a4edc948cbcff41d~mv2.png Periodic safety update report prepared under MDR Article 86 for a class IIb medical device https://www.medexeurep.com/post/reprocessing-single-use-devices-article-17 2026-09-06 https://static.wixstatic.com/media/78313a_89b6e5ba46d343369ae80d2d57b2dab6~mv2.png Single-use medical device assessed for reprocessing under the requirements of MDR Article 17 https://www.medexeurep.com/post/class-i-medical-device 2026-08-15 https://static.wixstatic.com/media/78313a_cea59b3ee1f4408d90921143bd3e80cd~mv2.png https://www.medexeurep.com/post/sell-medical-devices-in-europe 2026-08-30 https://static.wixstatic.com/media/78313a_a771107e8e0c4004b3c08e180c822e01~mv2.png MDR Article 11 route for non-EU manufacturers selling medical devices in Europe without an EU office https://www.medexeurep.com/post/notified-body-mdr 2026-09-09 https://static.wixstatic.com/media/78313a_f0bb7aefc79145efb1586cbd4ce7e754~mv2.png Which MDR device classes require a notified body under Article 52, and what its certificate covers https://www.medexeurep.com/post/distance-selling-medical-devices-eu 2026-09-06 https://static.wixstatic.com/media/78313a_26dda9cfee404019befbde4970b27c74~mv2.png Online medical device order arriving in the European Union, illustrating MDR Article 6 distance sales requirements https://www.medexeurep.com/post/systems-and-procedure-packs-article-22 2026-09-06 https://static.wixstatic.com/media/78313a_eb596ea5915444cc9841b493471a6b81~mv2.png Sterile surgical procedure pack tray illustrating MDR Article 22 obligations for systems and procedure packs https://www.medexeurep.com/post/medical-device-importer 2026-08-15 https://static.wixstatic.com/media/78313a_3d0a488e3a994619ba82b1989b6c4977~mv2.png https://www.medexeurep.com/post/medical-device-symbols 2026-08-30 https://static.wixstatic.com/media/78313a_d38d89988c5d4771854bd92834430238~mv2.png https://www.medexeurep.com/post/gspr-annex-i-checklist 2026-09-06 https://static.wixstatic.com/media/78313a_dd86c411b53c4207bafc5c6683d07d18~mv2.png Requirement-by-requirement conformity mapping representing the MDR Annex I general safety and performance requirements checklist https://www.medexeurep.com/post/ce-marking-medical-devices 2026-08-29 https://static.wixstatic.com/media/78313a_6e5de740ec8342669173407443f924e0~mv2.png https://www.medexeurep.com/post/no-eu-authorised-representative-consequences 2026-09-06 https://static.wixstatic.com/media/78313a_bc2318a1b94742f589e58937c22bb409~mv2.png Suspended medical device consignment at an EU border, illustrating enforcement against manufacturers with no EU authorised representative under MDR Article 11 and Regulation (EU) 2019/1020 https://www.medexeurep.com/post/technical-documentation 2026-08-30 https://static.wixstatic.com/media/78313a_2f6c2aa3aa1a4eea87af59c1a242ac46~mv2.png https://www.medexeurep.com/post/is-my-product-a-medical-device 2026-08-30 https://static.wixstatic.com/media/78313a_70907d62de8d4fc7b5666cce3973b896~mv2.png MDR Article 2 test for whether a product qualifies as a medical device in the EU https://www.medexeurep.com/post/ivdr-classification 2026-08-30 https://static.wixstatic.com/media/78313a_98d700c318b84d6f8fcccafb1a429b4f~mv2.png https://www.medexeurep.com/post/change-of-authorised-representative 2026-08-30 https://static.wixstatic.com/media/78313a_b6b3d843b5274c7aad4ace56362f3c3c~mv2.png https://www.medexeurep.com/post/serious-incident-reporting 2026-08-15 https://static.wixstatic.com/media/78313a_d883c4c3da654b3a9ce1abf69835ce89~mv2.png https://www.medexeurep.com/post/eudamed-srn-registration 2026-08-30 https://static.wixstatic.com/media/78313a_ee3e75696eeb4f26b296ace3c218a35a~mv2.png EUDAMED actor registration under MDR Article 31 and how the Single Registration Number is issued https://www.medexeurep.com/post/basic-udi-di 2026-08-30 https://static.wixstatic.com/media/78313a_a2c5bf0f16864f57bdf2076396ab9f60~mv2.png https://www.medexeurep.com/post/eu-authorised-representative-mandate-agreement 2026-09-06 https://static.wixstatic.com/media/78313a_f689a3f9a92f40fba8fc22d7ca2b907c~mv2.png The written mandate between a non-EU manufacturer and its EU authorised representative under MDR Article 11 https://www.medexeurep.com/post/medical-device-label-language-requirements 2026-09-06 https://static.wixstatic.com/media/78313a_0d4451756929409e95d260cca9c1c56e~mv2.png Multilingual medical device label and instructions for use illustrating MDR 2017/745 Article 10(11) national language requirements https://www.medexeurep.com/post/eudamed-mandatory-legacy-device-registration 2026-08-30 https://static.wixstatic.com/media/78313a_95e34af1cb9945868d8038ac6338e00e~mv2.png https://www.medexeurep.com/post/free-sale-certificate 2026-08-15 https://static.wixstatic.com/media/78313a_74c53e3b47b64436a5ee75c42a2a4114~mv2.png https://www.medexeurep.com/post/can-authorised-representative-be-importer 2026-09-06 https://static.wixstatic.com/media/78313a_b5548ad936aa450ba5c9331c1cf26d6f~mv2.png Comparison of the EU authorised representative role under MDR Article 11 and the importer role under MDR Article 13 held by one legal entity https://www.medexeurep.com/post/eu-rep-symbol-iso-15223-amendment 2026-08-02 https://static.wixstatic.com/media/78313a_cfb7118b79f14816bd872fa6e4de7cff~mv2.png https://www.medexeurep.com/post/eu-ar-uk-responsible-person-ch-rep 2026-08-15 https://static.wixstatic.com/media/78313a_d0c0de9f2441465e892d448547fd0f31~mv2.png https://www.medexeurep.com/post/eu-authorised-representative-cost 2026-09-06 https://static.wixstatic.com/media/78313a_58602156329941ffbf21302a49613167~mv2.png Breakdown of the cost drivers behind an EU authorised representative mandate under MDR 2017/745 Article 11, from risk class to documentation retention https://www.medexeurep.com/post/medical-device-registration-turkey 2026-08-30 https://static.wixstatic.com/media/78313a_baaf1ec0cf7145d7b9fb5a455274b905~mv2.png https://www.medexeurep.com/post/health-institution-exemption-article-5-5 2026-09-06 https://static.wixstatic.com/media/78313a_a5f9012a7b8e42b8982b13545d618d07~mv2.png https://www.medexeurep.com/post/implant-card-article-18 2026-09-06 https://static.wixstatic.com/media/78313a_26b8cf1dcb6a4b6282a8a19b1120fcdc~mv2.png Implant card supplied with an implantable medical device carrying the identification data required by MDR Article 18 https://www.medexeurep.com/post/medical-device-classification 2026-08-30 https://static.wixstatic.com/media/78313a_d852c2cb7f864f50a305d5c27dfcd8f6~mv2.png https://www.medexeurep.com/post/person-responsible-for-regulatory-compliance 2026-08-30 https://static.wixstatic.com/media/78313a_6319b72a4f8b4337bb2568576b02eb21~mv2.png https://www.medexeurep.com/post/class-i-qms-article-10-9 2026-09-06 https://static.wixstatic.com/media/78313a_3094bf7444a947d3a539b278c0f87b1d~mv2.png Quality management system documentation required under MDR Article 10(9) for a class I medical device https://www.medexeurep.com/post/eu-declaration-of-conformity 2026-08-15 https://static.wixstatic.com/media/78313a_2475fe6ec5834364ac3d4b15b030fdc8~mv2.png https://www.medexeurep.com/post/medical-device-distributor-obligations 2026-09-06 https://static.wixstatic.com/media/78313a_15f2e0cf2599485e8764f1cdd95005f5~mv2.png Medical device warehouse shelving representing MDR Article 14 distributor obligations and Article 16 relabelling rules https://www.medexeurep.com/post/medical-device-software-rule-11-ai-act 2026-08-15 https://static.wixstatic.com/media/78313a_fa29ca6bd4984d9bb0af8cac0e470066~mv2.png